RP-3.2.8Conflict of Interest and Conflict of Commitment

RP-3.2.8Conflict of Interest and Conflict of Commitment

1.Introduction

University relationswith industry, government agencies, individuals, and other enterprises outside theUniversity constitute a complex networkof interactions. These interactionshave directed attentiontopotential conflicts of values and interests between these entities and academia.Conflict of Interest isaddressed inSection3.8oftheBylaws of theBoardof Regentsasfollows:

3.8 Conflict of Interest. No employee of the University shallengage in any activity that in anyway conflictswith duties and responsibilities atthe University of Nebraska. The Board of Regentshas adopted Regents Policy 3.2.8andauthorizedthe implementation ofrelatedpolicies anddirectives to properly avoid, discloseand manage potential conflicts of interest.

In addition to Section 3.8 ofthe Bylaws, Nebraska statutes relating to conflict of interest and nepotismapplytoallpublic officialsand employees ofthe University, including the provisions of §49-14,101.01 oftheRevisedStatutes of Nebraska.3

Furthermore,federal funding agenciesrequire thattheUniversity establish safeguardsto preventemployees orconsultants from using their positionsfor purposes which are motivated by(or even giveappearanceof) adriveforprivate financial gain eitherfor themselves or familymembers. 4

Responsibility for assurance of compliancewiththispolicy restswiththe President and Chancellor ofeach campus. The Chancellorsshallsubmit anannualreport tothe President detailing the compliancepolicies, procedures and managementactivities at their campus.

2.University-Wide Conflict of Interest Principles

Campusconflict of interest policieswill vary according to the uniqueroles and needs of eachcampus.However, each campus policy must ensure thatbroadUniversity-wide principlesare followed,including:

1)Prospects of financial gainmust not unduly influence faculty and the University with regard tocommercially imminent, product orientedresearchprogramsversus fulfilling the University’sobjectives of educatingstudents, advancingbasic knowledge andserving Nebraskansthrough the development and application of knowledge that enables them to develop betterlives, strongercommunitiesand genuineeconomicopportunity.

2)The University must avoid situations where the possibilities for personal gain for the CoveredPerson may be judged to be sosignificant that itis unreasonable toexpecttheCovered

3“Apublicofficialorpublicemployeeshallnotuseorauthorizetheuseofhisorherpublicofficeoranyconfidentialinformationreceived

throughtheholdingofapublicofficetoobtainfinancialgain,otherthancompensationprovidedbylaw,forhimselforherself,amemberofhis orherimmediatefamily,orabusinesswithwhichtheindividualisassociated.”and"Apublicofficialorpublicemployeeshallnotuseorauthorizetheuseofpersonnel,resources,property,orfundsunderhisorherofficialcareandcontrolotherthaninaccordancewithprescribedconstitutional,statutory,andregulatoryproceduresorusesuchitems,otherthancompensationprovidedbylaw,forpersonalfinancialgain....“

4IncludingPublicHealthService,NationalInstituteofHealthandNationalScienceFoundationregulationsandguidelines(42CFRPart50,SubpartFand45CFRPart94.1),DepartmentofEducationregulations(34CFRPart75.524,34CFRPart75.525and34CFRPart74.42),andFDAregulations(21CFRPart54).

Personto exercise the objectivity necessary for publictrust in the University and the rigor ofits research.

3)Research agreements should encourage thefree exchange of ideas andthesharing ofresearch results regardless ofthe sponsoring entity.Some constraints mayberequired toprotect proprietary information or intellectual property.

4)Totheextent practicable and consistentwith applicable law, the University mustbeappropriately compensated for private, commercial use of the publicproperty under itsstewardship.

Underlying these principles isthe recognition thattheUniversity of Nebraska is apublic institution with amission of serving the people of Nebraska throughresearch, teaching andservice.

3.Annual Report

Annually, each campusshall submit a written conflict of interest report to the President which includesatleast the following information:

1)The number of conflictsdisclosed, by appropriateacademicunit.

2)Asummary of the nature of the conflicts.5

3)The number of conflictsbeing managed throughwritten plans,bycollege.

4)The number of conflictseliminated, by college.

5)Other material or information related to themanagement of conflicts of interest at the campus.

4.Personnel Affected by Conflict of Interest and Conflict of Commitment Policy

Covered Personshall mean:

1)University administrative officers and employees,specifically including anyUniversityemployees with delegated signature, purchasing or contracting authority on behalf of theUniversity;

2)University employees and faculty engaged inoutside employment or other activities specifiedin this policy (tech transfer/use of University facilitiesor equipment) that may create aConflictof Interest; and

3)Sponsored Research investigators,including University employees, faculty, staff and supportpersonnel (managerial/professional andoffice/servicepositions), volunteers, trainees,students, contractors and other persons under thedirect control ofthe University ofNebraska, whether paid by the University of Nebraskaornot,who participate inSponsoredResearchasdefined in Section 6 of this policy 3.2.8.6

Conflict of Interest shall mean situationswhen a Covered Person’sdirect or indirect personalfinancialinterests maycompromise,orhavethe appearance ofcompromising, theCovered Person’sprofessionaljudgment or behavior incarrying outhisor her obligations to the University of Nebraska. This includes

5Conflictsmaybeidentifiedaccordingtobasiccategories,forexample,conflictsarisingfromownershipofstock,familyrelationships,potentialundueinfluence,andthelike.

6ThetermCoveredPersonincludesthedefinitionofan“Investigator”underNIHguidelines,specifically“thePrincipalInvestigatorandany

otherpersonwhoisresponsibleforthedesign,conduct,orreportingofresearchfundedbytheNIH,orproposedforsuchfunding.Thedefinitionincludescontractorsorcollaborators,aswellastheInvestigator’sspouseanddependentchildren.”SeeResponsibilityofApplicantsforPromotingObjectivityinResearchforwhichPHSFundingisSought(42CFRPart50,SubpartF,grantsand45CFRPart94,contracts).

indirect personal financial interests ofaCovered Personthat may be obtained throughthird partiessuchas a CoveredPerson’sImmediate Family, business relationships, fiduciary relationships, or investments.

Immediate familyshall mean an individual who isthespouse, child, parent, brother, sister, grandchild, orgrandparent, by blood, marriage, oradoption of theCovered Person.

5.Individuals and Organizations Responsible for Administration of Conflict of Interest and Conflict ofCommitment Policy

At the University of Nebraska, all reporting of potentialConflictsof Interest should be undertaken with thegoal of full disclosure. ThePresident and Chancellors of each campusshall develop and implement adisclosure process andsupporting proceduresconsistent with the principlessetforth in this Policy,covering, at a minimum, sponsoredprogramsadministration, institutional reviewboards, any office oftechnology transfer, and any other responsible campusadministrative officers.The Chancellorsshall beresponsible for overseeingtheir campus’ reporting process and mustdesignatean administrative officerwhowill be in charge of developingmore specificwritten proceduresfor enforcing the policy. EachChancellorshall submit their campus’ processes and procedures tothe President for reviewandapproval.

The procedures for disclosure at each institution must, at a minimum, include the following:

1)Annual disclosures by Covered Personswho may have potentialConflictsof Interest.

2)A description of the process for developing, implementing, and overseeing conflictmanagement plans, including a detailed process for managing and/or eliminatingpotentialConflicts of Interest.

3)A description of procedures for ensuring coordinationamongallUniversity organizations witharolein oversight of conflicts.

4)A description of the process by which aCoveredPersonmay addressconcerns regardingaConflict of Interest situation or the management thereof.

5)A description of how:

• Disclosureswillbe reviewed and retained, andthe level ofactivity ofeachcollege onthecampuswill be reported tothe President pursuant to paragraph 10of this policy;

• Responsible campus officials areto reviewand manage potentialConflicts ofInterest;

• The campus will provide related trainingand advice about Conflict of Interest issues;

• The campuses will reviewandvalidate their programona regular basis;

• The campuswill make its implementation proceduresfor this policy available publicly;and

• The institution will enforcethis policy and providesanctions when necessary.

6.Conflicts ofInterestInvolving Sponsored Research

Research is basic tothe University's teaching and service missions.Good teaching and learning dependupon research. Likewise, through its research, teaching, and service activities, the University'sresourcescan best be brought to bear on public issues requiringobjective, systematic study. Research forms aninherent part of departmental and collegiate missions,and bringsrecognition tothe University anditsfaculty. All forms of research, which arewithin departmental andcollegiate missions, and which maintainthe high quality characteristic of the University, are appropriate to the University'sopen environment.

Similarly, University teaching andservice activities have potentialfor commercial use and development.

Sponsored Researchmeans research, training, and instructional projects performed by Covered Personsusing any University space,materials, equipment orproperty that involves funds, materials or othercompensation from sources outside theUniversitythrougha grantor contract that obligatesthe Universityto a specifiedstatement of work, sets forth binding financial terms intheformofa budget or up-frontpayment, or containsterms related to ownershipof and rightsto use intellectual property developedthereunder. Sponsored Research is a vital endeavor ofthe University; it allows faculty the means topursue excellence intheir research and scholarly activity, it expands opportunities for graduate andundergraduate student participation in research, itenhances the quality of University researchfacilitiesthrough public and private support, and it helps facilitate the commercialization of research andtechnology tobenefit the University andNebraska.The University encourages its faculty and staff toengage in both sponsored and non-sponsored research recognizingthat compliancewiththispolicycanhelp assure that appropriate standards of accountability are met and extramuralconsiderations do nothinder the dissemination orcommercialization of research.

Each campus shall establish itsown SponsoredResearch application approval process, includingapplicable internal or external peer reviewsystems and implementing best practices for approvingfederally, publicly and privately sponsored researchprojects. The Chancellor shall be responsible foroverseeing the research approval process and mustdesignate an administrative officerwho will beincharge of developing morespecificwritten proceduresfor implementing the policy. The procedures forSponsored Research approval at eachcampus mustataminimum include procedures for disclosing,identifying, reviewing, managing and reporting conflictsand potential conflicts that arisewith regard toSponsored Research on their campuspursuant to Article 3 of this policy.

7.Openness ofResearch and Publication ofResults

The traditions of free exchange of ideasand prompt dissemination of knowledgeare fundamental to theUniversity'smission and should governall research, teaching, and service activities conducted byUniversity faculty, staff and students. The University is committedto an open teaching and researchenvironment, which ensures free faculty and studentexchange of ideas, thereby contributing to theadvancement of knowledge inall disciplines. Asfar aspossible, the acceptanceof support external to theUniversity should not create situations whichcurtail open discussion ofthe research among colleaguesand students.

Industrytypicallytreatstheproducts of its researchina very confidential manner. On occasion, industryexpectsproject participants tomaintainthesame degree of confidentiality with sponsored research. It isimportant to note that openness, freedom of discussion, and freedom to publishgo to the very core of theUniversity. Nonetheless, there arecertain legitimateneeds for confidentiality on the part of industry thatmust be metby Sponsored Research investigators. Data received froman industry sponsor and marked"confidential" may be kept in a confidential status forastated periodoftime.Also,itisprudent torecognize theneed to maintain the confidential status ofthe results oftheprojectfora period oftimesufficient to determine patentability and filing of patent applicationsor as agreed upon inan agreementbetween thesponsor and the University. When appropriate, the University may enter into confidentialagreements to protect proprietary information, where thisis deemed necessary, either through directagreement with an industrial sponsor orthroughan agreement between the sponsor andaUniversityemployee.

The campus official responsible for administration of research orother campus official designated bytheChancellor must ensure thatallindividualswho participate in industry-sponsoredresearch projects arefully informedin writing of the ownershipand disposition of inventions and requirements of confidentialityregarding research resultsand other confidential information provided by the sponsors ofsuchprojects.

Research conducted byfaculty under industry orothercommercialsponsorshipmust,asfar aspossible,maintain theUniversity's open teaching, research, and service environment.

The campus official responsible for administration of research orChancellor’sdesignee must review andapproveanynew, proposed, or ongoingfaculty-industry interactionsas these interactionsmightcompromise the University'sopen teaching and research environment. The appropriate departmentchair(s) ordirector(s), dean(s), and in rare circumstances, the individual designated to perform thecomplete administrative review asdescribed in Section1--shall aid inthis process andshallseek toresolveall potential problems prior to the approval of such interaction.

The campus official responsible for administration of research orChancellor’sdesignee shall fromtimetotime providecurrent information to the departmentchairs, deans, directors and faculty pertinentinformation for timely reporting ofconcerns regarding violationofthe Conflict of Interest and Conflict ofCommitment policy.

Faculty must have the rightto disseminate theirresearchresults, indeed are obligated todoso.TheUniversity discourages individual faculty from agreeingtoforego thisbasicright. Likewise, theUniversitywill not unilaterally forego this right on behalf of its faculty, staff and students. However, the University andfacultymayaccept reasonable delays insubmission ofnew findings for publication or other release ofinformation to enablesponsors orthe University to obtain proprietary or patent protection, for example. Inspecialcircumstances tobe determined bythe University, aresearchermay waive his or herright todisseminate the results ofhisor her research and elect to enter anagreement to maintain theconfidentialityof proprietary research for specified periods of time.7

The campus official responsible for administration of research orChancellor’sdesignee shall workwithfaculty engaged in industry-sponsored projects to provide written notification to support personnel andstudents involved intheseprojects, describing all contract and grant terms affecting them, including thepossibility of delays in publication caused by the need ofthe sponsor to reviewmanuscripts orany otherobligationsofconfidentiality. Graduatestudents must notbe assigned to thesisresearch topics whichmightbeaffectedby confidential agreements. The appropriate campus official or Chancellor’s designeemay authorize exceptionswhere appropriate.

8.Outside Employment andConflicts of Commitment

The University not only permits butexpressly encourages faculty to pursueoutside professional activitiesincluding interactionswithindustry, with or without compensation,which will enrich a faculty member'sacademiccontributionsto the University. Consulting can expose faculty to research problemsandperspectiveswhich may enrich faculty teaching, research, extension, and service backgrounds. However,facultyand administrationmustbesensitive thatsuchinteractionscould causeConflicts of Interest andmust ensure that CoveredPersonsdo not make unnecessary or inappropriate commitmentsof their timeor expertisewhich can adversely affectthe University and its mission. A conflictof commitment must bedisclosed andmanaged when it constitutes aConflictof Interest for aCovered Person.

The assumption thatCovered Personswill devote their time and effort to the University in proportion totheir appointments--that full-time appointment connotes full-time commitment oftime, effort, andexpertisetothe University--is inherent in University employment. Outside consulting activities, often acceptable inthemselves, can interfere with a University employee’s paramount obligationsto the University by placingsignificant, competing demands upon thetimeand energy ofaCovered Personwith the potential for theneglect of instructional, research and other employment obligations. In some circumstances,aCoveredPerson’sproposed outside activities may directly conflictwith the objective of assignments within theUniversity.

The University, through anoutside employment policyenacted by the Board of Regents, seeks tominimize the potential for conflict of commitment by several mechanisms. The time that may be devotedto outside activity is normally limited to two working days per month; greater time commitments requirespecific approval of the Board ofRegents. (Forpractical reasons, facultyare given considerable freedomin the scheduling of any outside activities.) In addition, the University must examine the application of anemployee's expertise to proposed educational, industrial,or otherconsulting activities to assure that anyConflict of Interest and/orconflict of commitment is properly disclosed and managed. Hence, theUniversity requiresprior disclosure of proposed consulting, extramural teaching, orother activities to thedepartment chair and the prior approval ofthe collegedean and campusadministration. Suchdisclosuremay be madeby completing the appropriate campus form for disclosure of outside employment and mayrequire the provision of additional documentation to the chair, dean, or other administrator.

Incertain other circumstances, the specific approval of theBoardof Regents may be required.Therelevant policy of the Board of Regents is set forth inSection 3.4.5of theBylaws of Board of Regents.

Outside Activity and Employment. As University-industry relationships increase witha growingdesire forconsultantships and otherprofessionalactivitiesoutside the University, University employees mustcontinue to observe the University policy on outsideemployment embodied inSection 3.4.5of the Bylawsof the Boardof Regents. In addition, University employees mustobserve theBoardof Regents policy onConflict of Interest stated in Section 3.8of the Bylaws of the Board of Regents. Accordingly, eachcampusshall developappropriate forms for employees to disclose 1)potentialConflicts ofInterest, and2) outsideemployment in order for review, documentation, approval and management ofConflictsof Interest andoutside employment.

Department chairpersons,department heads, deans, and directors have primary responsibility toreviewthe specific nature of eachproposed outside professional activity withintheirrespective areas ofadministrative responsibility

7Anexampleofsuchacircumstancewouldberesearchperformedpursuanttoacontractwithanagencyofthefederalgovernmentrequiringsecurityclearance.

and to deny approval to any such activity which would interfere with thenormal University duties ofthe employee involvedand to require proper disclosure and management ofany Conflict of Interest.

It is impossible to anticipate all questionswhich may arisein connectionwiththe applicationofSection

3.4.5of the Bylaws tothevaried outside professionalactivitiesof employees. However,several generalguidelines are set out belowto assist inthe administration of this policy:

1)Section 3.4.5 of theBylaws does notapplytoOfficeand Servicestaff.

2)Section 3.4.5(a) of theBylawsrequires Regental approval of outside professional activitieswhere the employees will accept retainer fees or other remuneration on a permanent or yearlybasisas aprofessionalconsultant.Thekey consideration indeterminingwhether there will be acceptance of a retainerfee or remuneration on a permanent yearly basisis the natureoftheprofessionalbusiness relationship betweenthe employee and hisor her client or patient. If this business relationshipisone where the employee isobligated atthebeginning ofthe professional relationship witha client orpatienttoprovide professionalservicesover a period of one year orlonger, then approval by the Boardof Regents isrequired.

3)In addition to obtainingprior approval ofthe department chair and campusadministrator,Section 3.4.5(b) of theBylawsrequiresRegental approval of outside professional activityrequiring morethanan average oftwo days permonth during the period ofthe employee’sfull-time employment. TheBoardof Regents has interpreted thislanguage to mean two daysper month during the assigned work week. For thisreason, Regentalapproval will onlyberequired when an employee's outside professionalactivities will prevent the performance ofhis or her assigned dutiesat the University more than an averageoftwodays per monthduring the period of full-time employment.

4)Section 3.4.5 of theBylawsrequiresRegental approval ofoutside professional activityinvolving the charging of fees forwork performed in University buildingswith Universityequipment and materials. The President and Chancellors are authorized to develop specificpolicieswith regard to the charging of feesforwork performed inUniversity buildings withUniversity equipment and materials.

5)Section 3.4.5 of theBylawsdoes notrequire individual approvalofeach separate client orpatientrelationship for professionalssuch as accountants, engineers,architects,lawyers,psychologists, therapists, etc. It is sufficient thatthe nature of the outside professional activitybe generallydescribedsothat appropriate evaluation maybe conducted regarding potentialinterferencewith University duties,Conflict of Interest, and conflict of commitment. So long as noneofthe circumstancesrequiring Regental approval undersubparagraphs (a),(b),(c), and (d) of Section3.4.5 of theBylawsexist,no further information need be providedby theemployees, and the professional activitymay be approved by the chancellor upon therecommendation ofthe appropriate deanor director.

6)Activitiesfora professional organization with which an employee is associated donotconstitute thetype of professional activity coming within the scopeof Section 3.4.5 of theBylawsunless a professional service isprovided to the organization for which the employeesispaida professional fee which iscommensurate with theactualvalueofthe professionalservice provided.

The foregoing should notbe construedtorelieveanyemployeeof complying with applicablepolicies orregulationsof the department, college, division, campus, orUniversity with regard to time one is allowedawayfromregularUniversity duties.

University employees proposing outsideemploymentora consulting relationshipof any naturepursuantto Section 3.4.5 of the Bylaws are required to complete the appropriate campus form for disclosure ofoutside employment.

Furthermore,consistent with the foregoing policystatement regarding conflicts ofcommitmentandtheeffect such conflictscan have ona faculty member’s research programsand theduties faculty membersowetheUniversity, University employees proposing outside employment ora consulting relationship witha third party shall disclose to the University any:i) confidentiality or non-disclosure agreements, ii) non-compete agreements orany agreement containing anon-competeclause, iii) assignments ofintellectualproperty rights tothe contracting party, andiv) involvement with commercial or educationalenterpriseswhere the name ofthe University maybe used for commercial gain tothe Chancellor ortheChancellor’sdesignee. Although agreements ofthistypecanbe problematic, the University shall endeavor to promptlyreviewsuch agreements and resolveanypotential conflict of commitment to allow the Universityemployeetoperform the proposed outside employment or consulting while maintaining the integrity oftheir researchprojects and commitments to the University.